Status:
TERMINATED
A Study to Determine the Performance of the Press Fit Condylar (P.F.C.) Sigma RP-F Knee System
Lead Sponsor:
DePuy International
Conditions:
Osteoarthritis
Eligibility:
All Genders
45-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate if the P.F.C. Sigma RPF knee accommodates functional stability with a post-operative passive range of motion of greater than 125° of flexion and to demonstrate...
Detailed Description
Primary endpoint is to demonstrate that 90% of patients have a functionally stable knee that can achieve post operative range of motion of 125 degrees or greater. The secondary endpoint is to investi...
Eligibility Criteria
Inclusion
- Male or female subjects, aged between 45 and 75 years inclusive.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- Subjects who are able to achieve a pre-operative passive range of motion of equal to or greater than 110º.
- Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects who present with idiopathic osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty.
- Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the P.F.C.® Sigma RPF knee, according to the indications specified in the package insert leaflet.
Exclusion
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical study with an investigational product in the last month (30 days).
- Subjects who are currently involved in any personal injury litigation claims.
- Subjects with a known history of poor compliance to medical treatment.
- Subjects who have a pre-operative limb deformity of equal to or greater than 10° varus or 15° valgus as defined using the anatomical axis.
- Subjects who have morbid obesity i.e. BMI ≥40.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00761410
Start Date
October 1 2004
End Date
May 1 2015
Last Update
June 20 2016
Active Locations (8)
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1
The Nook, 51/B SV Road
Mumbai, Maharashtra, India, 400 054
2
Kobe University Graduate School Of Medicine, 7-5-1 Kusundki- cho
Chūōku, Kobe, Japan
3
Wellington School Of Medicine Surgical Research Trust, Main Street
Newtown, Wellington Region, New Zealand
4
Tan Tock Seng Hospital, No 11 Jalan
Tan Tock Seng, Singapore, 308433